Coordinates customer and regulatory requests, prepares documentation and submissions, and supports registrations, certifications, permits, and other regulatory approvals.
Compensation
Expected base salary: $75,000-$85,000 USD, depending on experience, qualifications, and internal equity
Responsibilities
Manage regulatory and customer inquiries through Salesforce
Prepare documentation and submissions
Support registrations, certifications, permits, and other regulatory approvals
Maintain accurate, up-to-date regulatory data in Salesforce
Improve digital workflows and case-handling practices
Lead compliance program administration, technology enablement, process improvement, analytics, and regulatory implementation to strengthen the effectiveness and maturity of the Compliance Program.
Compensation
Base Pay Range: $92,400 to $115,000 annually
Responsibilities
Lead and support compliance program administration activities, initiatives, and projects designed to strengthen the effectiveness, scalability, and maturity of the Compliance Program.
Identify opportunities to leverage technology, analytics, workflow automation, and artificial intelligence to improve Compliance Program effectiveness, operational efficiency, and regulatory compliance.
Support the implementation, optimization, administration, and continuous improvement of compliance technology platforms, reporting solutions, regulatory libraries, and workflow management tools.
Coordinate and monitor implementation of federal and state regulatory requirements, ensuring actions are assigned, tracked, documented, and completed in collaboration with Compliance and business stakeholders.
Serve as a liaison between Compliance, business operations, and technology teams to facilitate successful project execution, regulatory implementation, and program initiatives.
The Compliance Operations Specialist supports the day-to-day execution of licensing and works closely with Legal, Product and regional teams to ensure operational readiness.
Responsibilities
Manage the tracking of regulatory obligations, licensing conditions, and operational actions
Prepare SOPs, implementation checklists, and management reports
Coordinate cross-functional activities with Legal, Product, and regional teams
Support audits, regulatory inspections and operational reviews by coordinating documentation and evidence gathering
Conduct operational gap assessments and identify areas for improvement through remediation initiatives
Senior Regulatory Affairs Specialist responsible for managing regulatory submissions, pharmacovigilance, and quality compliance for animal health medicinal products in Sweden.
Responsibilities
Lead and coordinate new marketing authorization applications for veterinary medicinal products and line extensions
Prepare and submit regulatory variations, ensuring compliance with local and global requirements
Develop, review, translate, and maintain product information, including SPCs, labeling, and packaging materials
Collaborate with global Regulatory Affairs, Pharmacovigilance, and Quality teams
Manage adverse event reporting and product quality complaint handling in compliance with applicable regulations
Requirements
Master's degree (MSc) in Pharmacy, Veterinary Science, Life Sciences, or another relevant scientific discipline
Lead and develop the Process Compliance team to strengthen operational performance and sustainable compliance within Manufacturing Operations.
Responsibilities
Lead the Process Compliance programme, setting priorities, governance frameworks and improvement strategies across Manufacturing Operations.
Establish compliance assurance processes using audits, self-inspections and quality reviews to identify risk and support inspection readiness.
Provide governance and oversight of quality events, investigations, CAPAs and quality system actions, ensuring sustainable corrective actions are implemented.
Identify, assess and manage compliance risks, escalating significant issues and ensuring effective mitigation.
Lead compliance improvement initiatives that strengthen quality system effectiveness and operational performance.
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